X-spine Announces FDA Clearance of New Implant System

MIAMISBURG, Ohio--(BUSINESS WIRE)--X-spine, a global leader in the design and manufacture of devices for the treatment of spinal disease, announces a new USFDA clearance for the Silex™ sacroiliac (SI) joint fusion system.

“The Silex™ system achieves an efficient fixation of the SI joint while respecting the established principles of bone grafting and fusion to create long-term stability.”

The newly-cleared Silex™ system allows for fusion and stabilization of the SI joint in eligible patients whom appropriate non-surgical treatment has failed. The device can be placed through a small incision, and incorporates a proprietary dual-pitch compression-thread design and titanium plasma coating to stabilize the SI joint in fusion procedures. The design of the implant allows for bone graft to be introduced into the joint and implant in order to achieve a solid fusion.

Unlike some recently-introduced SI arthroplasty-type systems which are not compatible with direct bone grafting of the SI joint space, the Silex™ is a true bony fusion and arthrodesis system. The implant and instrumentation suite allows for direct exposure and preparation of the SI joint surface, placement of bone graft into the SI joint space under direct visualization, and placement of bone graft directly within the Silex™ implant itself.

“Sacroiliac dysfunction is an important cause of pain and disability which has, until recently, been underdiagnosed and undertreated,” states David Kirschman M.D., a former spine surgeon and President and CEO of X-spine. “The Silex™ system achieves an efficient fixation of the SI joint while respecting the established principles of bone grafting and fusion to create long-term stability.” The system was developed with intensive surgeon input with the goal of maximizing the efficiency and performance of the sacroiliac fusion procedure.

X-spine will be exhibiting the new Silex™ system, along with its complete line of spinal devices, at the American Association of Orthopaedic Surgeons Meeting in Chicago, March 20^th through 22^nd.

The Silex™ SI joint fusion system joins X-spine’s continually expanding portfolio of innovative spinal devices, including the AXLE™ Interspinous Fusion System, Certex™ Cervico-thoracic Fixation System, the CALIX PC™ Titanium-coated Intervertebral Fusion System, the FIXCET™ Facet Fixation System, the FORTEX™ and X90™ Pedicle Screw Systems, the SPIDER™ Cervical Plating System, and the HGRAFT™ Spinal Allograft System.

Founded in 2003, privately-held X-spine Systems, Inc. (www.x-spine.com) designs and manufactures surgical implants and instrumentation for use in spinal surgery. With facilities in Ohio and the Netherlands, X-spine brings its philosophy of inventive products, simplicity of design, and intuitive function to spine surgeons and patients worldwide.